WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D
FDA premarket approval P130013/S070 · decided 2024-09-23
Approval details
- PMA number
- P130013
- Supplement
- S070
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2024-06-27
- Decision date
- 2024-09-23
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for replacing a manual inspection with an automated inspection method, including modified acceptance criteria, to detect bent struts on the device frame for WATCHMAN FLX LAA Closure Device and WATCHMAN FLX Pro LAA Closure Device.
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